Article
Sustained and similar clinical response to etanercept after 6 years of treatment in patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis: long-term results of the ESTHER trial
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Authors
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Denis Poddubnyy
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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In-Ho Song
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Kay-Geert Hermann
- Charité - Universitätsmedizin Berlin, Radiologie, Berlin
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Hildrun Haibel
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Johanna Callhoff
- Deutsches Rheuma-Forschungszentrum (DRFZ), Programmbereich Epidemiologie, Berlin
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Joachim Listing
- Deutsches Rheuma-Forschungszentrum (DRFZ), Programmbereich Epidemiologie, Berlin
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Beate Buß
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Ekkehard Lange
- Pfizer Pharma GmbH, Berlin
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Martin Rudwaleit
- Klinikum Bielefeld Rosenhöhe, Bielefeld
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
| Published: | September 1, 2015 |
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Outline
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Introduction: The objective of the current work was to assess the long-term clinical efficacy of etanercept (ETN) in patients with early axial spondyloarthritis (including both non-radiographic axial SpA – nr-axSpA and radiographic axial SpA – ankylosing spondylitis, AS) with a symptom duration of < 5 years who participated in the long-tem (until year 6) extension of the ESTHER trial.
Methods: In the previously reported core phase ESTHER trial axial SpA patients were treated with ETN (n=40) versus sulfasalazine (n=36) during 48 week. After one year all patients were treated continuously with ETN (a few (n=12) patients temporarily interrupted treatment in the 2nd year to assess time to flare and were then (re-)treated with ETN). Clinical efficacy data were analysed for patients who completed six years of treatment.
Results: Out of 76 patients who entered the study at baseline, 44.7% (n=34, 17 with nr-axSpA and 17 with AS) completed year 6 of the study. In both subgroups a constantly and similarly good clinical response was observed until year 6 with more than a half of the patients in both groups reaching an ASAS partial remission response at year 6 (Table 1 [Tab. 1]). Similarly high and comparable between groups were ASAS40 response and a 50% improvement of BASDAI as compared to baseline. Mean BASDAI and BASFI values were constantly < 2 at years 4, 5 and 6 in both groups (Table 1 [Tab. 1]).
Conclusion: There was a sustained and similar clinical response in patients with nr-axSpA and AS treated with ETN over 6 years. Similar clinical response indicates that the presence or absence of radiographic sacroiliitis at baseline does not determine clinical response to anti tumour necrosis factor therapy over time that supports the concept of axial SpA as one disease.
